Kornimate/medical-research-clean huggingface dataset:
is the 3d-panc msp model superior to ct for assessing response to neoadjuvant treatment in pca patients?

Conditions: Adenocarcinoma of the Pancreas

Summary: prospective multicenter study in which all patients with borderline or locally advanced pancreatic adenocarcioma undergoing neoadjuvant chemotherapy and surgical exploration with curative intent will be included for one year. preoperative images by traditional ct and 3d-msp technology will be evaluated, comparing the accuracy variables (sensitivity, specificity, predictive values, area under the curve, concordance index) of both techniques with the gold standard (results of surgery and histopathological analysis).

neoadjuvant chemotherapy followed by surgery represents the treatment of choice for patients with borderline and locally advanced pancreatic adenocarcinoma (pac). despite being the diagnostic technique of choice for pac staging, computed tomography (ct) has a very low accuracy in detecting those patients who may benefit from surgical resection after neoadjuvant chemotherapy. consequently, the study of computerized image processing technologies is gaining importance. however, there are no prospective validation studies of these technologies to determine their usefulness in the preoperative evaluation of pca patients undergoing neoadjuvant therapy. a prospective multicenter study in which all patients with borderline or locally advanced pac undergoing neoadjuvant chemotherapy and surgical exploration with curative intent will be included for one year. preoperative images by traditional ct and 3d-msp technology will be evaluated, comparing the accuracy variables (sensitivity, specificity, predictive values, area under the curve, concordance index) of both techniques with the gold standard (results of surgery and histopathological analysis). a prospective, multicenter study with control group will be performed. since this is the evaluation of a diagnostic test, it will not be necessary to randomize the patients included, since each patient will be evaluated by means of both techniques under study, thus serving as his or her own control.

Eligibility criteria:
inclusion criteria: - patients with a diagnosis of borderline or locally advanced pac of the head of the pancreas, as defined by the national comprehensive cancer network (nccn), who have received neoadjuvant treatment and who undergo surgical exploration with resective intent. exclusion criteria: * patients younger than 18 years of age. * patients under 18 years of age. * disease progression during neoadjuvant treatment. * no preoperative ct scan. * refusal to participate in the study.
change in thrombin generation potential and thromboelastography during the menstrual cycle

Conditions: Von Willebrand Disease

Summary: the primary objective of this study is to describe characteristics and trends for thrombin generation (tg) and thromboelastography (teg) at 4 time points during the menstrual cycle.

we propose that tg and teg will be more sensitive than traditional coagulation assays to detect physiologic variation in hemostasis, fibrinolysis, and platelet activation throughout the menstrual cycle. we expect that tg and teg will better discriminate patients with vwd than traditional coagulation studies during the menstrual cycle. in this study we plan to measure tg and teg in healthy women and women with von willebrand's disorder during four phases of the menstrual cycle. we will compare specific measurements of endogenous thrombin generation potential from the tg and fibrinolysis and platelet activation from the teg with standard measures of coagulation, fibrinolysis, and platelet activation markers during the menstrual cycle.

Eligibility criteria:
inclusion criteria: * females of reproductive age with regular menstrual cycles and a diagnosis of von willebrand disease according to the international society of thrombosis and hemostasis diagnostic criteria. exclusion criteria: * females who are pregnant, or have a history of endocrinopathy or hormone imbalance * history of hysterectomy or bilateral oophorectomy * history of ovarian or uterine cancer * use of intrauterine device * use of antifibrinolytic therapy, hemostatic agents, or anti-platelet agents.

Keywords: von willebrand disease healthy women and women with von willebrand disease
cognitive behavioral therapy for insomnia in type 2 diabetes mellitus

Conditions: Type 2 Diabetes; Insomnia

Summary: this study will explore the effects of cognitive behavioral therapy for insomnia (cbti) compare to health educations in patients with type 2 diabetes (t2dm) with insomnia symptoms.

this study will recruit participants with t2dm with insomnia symptoms and randomize them to weekly cbti or health education for 8 weeks. outcomes will be measured at baseline and 8 week, and 16 weeks (8 weeks post intervention). primary outcome will be subjective sleep quality as assessed by pittsburgh sleep quality index secondary outcomes will be fasting glucose, hemoglobin a1c, insulin levels, high sensitivity c-reactive protein, objective sleep parameters from accelerometer, depressive symptoms, daytime sleepiness, quality of life, anxiety symptoms and stress symptoms.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus age 30 to 65 years old * hemoglobin a1c ≥ 6.5 but ≤ 10 % * have poor sleep quality as assessed by insomnia severity index ≥ 15 * receive the same hypoglycemic treatments 3 months before the intervention * if using sleep aid, the dose needs to be stable for 3 months prior to the enrollment * ability to use the electronic devices (computer, tablet) and assess the internet * willing to attend all of the 8 sessions activities exclusion criteria: * type 1 diabetes mellitus * night shift work * insulin therapy * severe hypoglycemia who required hospitalization or emergency department visit in the past 6 months * history of diabetic ketoacidosis in the past 6 months * medically unstable conditions eg. renal replacement therapy, liver failure, heart failure, active cancer, epilepsy, unstable cerebrovascular disease * psychosis, uncontrolled depression * untreated obstructive sleep apnea or stop-bang ≥ 5 * language/communication/hearing/sight disability * pregnancy or lactation * care giver of infant * harmful alcohol/smoking (≥15 standard-drink in men and ≥8 standard-drink in women)

Keywords: cognitive behavioral therapy for insomnia
changes in inflammatory response after immunonutrition compared to standard nutrition in colorectal cancer tissue

Conditions: Colon Cancer; Nutrition Aspect of Cancer

Summary: it is randomized controlled trial, in which investigators will estimate the impact of the use of immunonutrition support compared to standard nutritional support in the preoperative period in patients with colorectal cancer.

the first choice of treatment in colorectal cancer is surgery. nutritional support in form of oral nutritional supplements (ons) in the preoperative period is widely accepted in reducing the incidence of perioperative complications and immunonutrition is generally recommended. however, there is little clinical data regarding the impact of such treatment on a tumor biology. investigators want to perform randomized controlled trial to explore the impact of the use of immunonutrition in relation to standard nutritional support in the preoperative period on alternating the expression of inflammatory response cytokines expression and leukocytes infiltration in tumor tissue in patients operated for colorectal cancer.

Eligibility criteria:
inclusion criteria: * diagnosis of colon cancer during preoperative colonoscopy confirmed by histopathological examination. exclusion criteria: * emergency/urgent operation * active infection * inflammatory bowel diseases in history * other systemic immune disorders * the necessity of preoperative neoadjuvant treatment (radiotherapy or chemotherapy) * metastatic disease, or local infiltration of cancer which was described as t4 stage in preoperative ct scan * patients who were not able to intake at least 85% of administrated ons doses

Keywords: immunonutrition colon cancer inflammatory response perioperative care randomized controlled trial
a triple-blinded, randomised, placebo-controlled trial to examine the efficacy and safety of vineuro in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: the investigational product is a specially formulated tcm and administered in the form of a capsule. basic pre-clinical studies have suggested that it may have good immunomodulating functions, increases the activities of t-cells, b-cells and nk cells, enhances mitochondrial antioxidant status on various tissues including brain tissues. therefore, this formulation may have special values in improving symptoms in parkinson's disease patients. the purpose of the study is to determine the efficacy and safety of vineuro in patients with parkinson's disease.


Eligibility criteria:
inclusion criteria: * a subject will be eligible for study participation if he/she meets all the following criteria: 1. age of at least 30 years 2. diagnosis of symptomatic, idiopathic parkinson' disease using the united kingdom parkinson's disease society brain bank diagnostic criteria (appendix 3 in the protocol) 3. stage 1-4 on the modified hoehn and yahr scale (appendix 4 in the protocol) 4. possesses three of the four cardinal signs of parkinson's disease, i.e. rigidity, bradykinesia, resting tremor and postural instability, without any other known or suspected cause for their parkinsonism 5. if receiving levodopa or other symptomatic treatments, the subject should have shown a good response to it and have been on a stable dosage for at least 1 month prior to study entry 6. voluntarily signs and dates an informed consent form, approved by an institutional review board (irb)/independent ethics committee (iec), prior to any study-specific procedures. exclusion criteria: * a subject will be excluded from the study if he/she meets any of the following criteria: 1. presence of atypical parkinsonian syndromes 2. dementia as defined by the mini-mental state examination score (appendix 5 in the protocol) of 22 or less 3. serious concurrent illness, such as active cardiac, renal, liver, or neoplastic disease 4. used centrally active therapies, e.g. hypnotics, antidepressants, anxiolytics, within 60 days before study entry 5. used methylphenidate, cinnarizine, reserpine, amphetamine, or monoamine oxidase-a inhibitors, e.g. pargyline, phenelzine, or tranylcpromine, within 3 months of study entry 6. has history of receiving any neuroleptics 7. used alpha-methyldopa or flunarizine within 6 months of study entry 8. females who are pregnant or breastfeeding. 9. subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study (visit 1). 10. subjects who are taking any traditional chinese medication, or has been taking any traditional chinese medication within the last 2 weeks prior to screening of this study (visit 1). 11. any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.

Keywords: parkinson's disease
be study of bilayer combination of gemigliptin/rosuvastatin 50/20mg in comparison to monolayer combination.

Conditions: Diabetes Mellitus, Type 2; Dyslipidemias

Summary: to evaluate and compare pk/pd, safety and tolerability of monolayer combination of gemigliptin/rosuvastatin 50/20mg and bilayer combination of gemigliprin/rosuvastatin 50/20mg in healthy adults.

to evaluate and compare pharmacokinetics/pharmacodynamics, safety and tolerability of monolayer combination of gemigliptin/rosuvastatin 50/20mg in comparison to bilayer combination of gemigliprin/rosuvastatin 50/20mg administered in healthy volunteers

Eligibility criteria:
inclusion criteria: * age: 19\~45 * body weight: 55kg or higher(female: 50kg or higher) and bmi 18\~27kg/m2 * sbp 90\~150mmhg, dbp 60-95mmhg * fasting glucose 70\~120mg/dl * infertility 1. surgically infertile 2. to prevent pregnancy, participants who agreed using 2 or more contraceptive methods. such as * barrier methods: condom, diaphragm, cervical cap (pessary), spermicide * hormonal methods: pills, injection (depot), skin patch, hormonal implant (implanon), vaginal ring * intrauterine devices (iuds): cooper iud (loop), hormonal iud (mirena) * natural methods: basic body temperature, ovulation period, coitus interruptus, abstinent * people who perfectly understood clinical trial and independently decided to participate in clinical trial. * people who will be able to collect blood sample during clinical trial period. * people who are suitable to participate clinical trial by physical examination, lab test and medical examination by interview. exclusion criteria: * genetic problems such as galactose intolerance, lapp lacatase deficiency, glucose-galactose malabsorption * clinically significant disease such as liver, kidney, digestive, pulmonary, endocrine system, cardiovascular disease etc. * people who have gastrointestinal disease or history of surgery which would affect absorption of drug. * history of clinically significant drug induced hyper-sensitive reaction or drug related muscular disease
safe and fast radial hemostasis using synergistic strategies: safe & fast trial

Conditions: Cardiovascular Diseases; Bleeding; Arterial Puncture; Catheter Complications; Occlusion of Artery

Summary: the safe and fast radial hemostasis using synergistic strategies (safe \& fast) trial is an interventional study aimed at reducing the incidence of radial artery occlusion (rao) rebound bleeding, and the required compression time after transradial approach (tra) procedures, which have become the default access for coronary procedures globally. the hypothesis is that combining lower-dose heparin and radial hemostasis with simultaneous ipsilateral ulnar artery compression could achieve these improved outcomes.

patients referred for diagnostic trans-radial cardiac catheterization who meet the inclusion criteria will be randomized into two groups. group 1 will receive a standard heparin dose (50 u/kg) with a total compression time of 2 hours using the tr band ® . group 2 will receive a reduced heparin dose (25 u/kg) and a compression time of 60 minutes using the vasoband™, with simultaneous ipsilateral ulnar artery compression. the study's primary endpoint is a composite of rebound bleeding, post-procedural rao, and hematoma formation. radial artery patency will be evaluated using ultrasonography. with an expected complication rate of 8.2% in group 1 and 4.5% in group 2, a sample size of 207 patients per group will provide an 80% power to demonstrate non-inferiority for the treatment group at the alpha 2.5% level. the statistical analysis plan will use descriptive statistics for baseline data and 95% confidence intervals for outcome variables. if non-inferiority is demonstrated, there will be a superiority test performed to examine if group 2 is superior. in conclusion, the safe \& fast trial intends to establish a safer, quicker protocol for hemostasis after tra procedures, with the potential to reduce patient recovery time and improve procedure throughput in cardiac catheterization laboratories.

Eligibility criteria:
inclusion criteria: 1. patients referred for diagnostic transradial cardiac catheterization 2. age ≥ 18 years 3. ability to provide written informed consent exclusion criteria: 1. absence of written informed consent 2. patients on long-term systemic anticoagulation therapy for a different indication 3. patients requiring a heparin dose of greater than 50 units per kilogram before, during, or after the procedure for any reason. 4. patients requiring greater than 6 french catheter access

Keywords: radial artery occlusion rebound bleeding transradial access coronary angiography
investigate the radical extent of lymphadenectomy of laparoscopic right colectomy for colon cancer(relarc).

Conditions: Colon Cancer

Summary: to investigate whether extended lymphadenectomy (cme) in laparoscopic colectomy could improve disease-free survival in patients with right colon cancer, compared with standard d2 radical operation.

our study design is a two-arm, parallel-group, single-blind randomized clinical trial. the enrolled colon cancer patients would be divided into the intervention group (cme group) and control group (d2 radical operation group). the postoperative adjuvant chemotherapy is determined by the pathological results. for patients of stage ⅲ and patients of stage ⅱ with unfavorable histologic features, six months of adjuvant chemotherapy of xelox or fluorouracil-based regimen are recommended. the postoperative examination should be performed every four months in the first two years and every six months in the following three years, to exclude local recurrence and distant metastasis. our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.

Eligibility criteria:
inclusion criteria: 1. patients suitable for curative surgery 18-75years old 2. asa grade i-iii 3. qualitative diagnosis: a pathological diagnosis of adenocarcinoma; 4. localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon; 5. enhanced ct scan of chest, abdominal and pelvic cavity: assessment of tumor stage is t2-t4n0 or tanyn+; there is no distant metastasis. 6. informed consent exclusion criteria: 1. simultaneous or simultaneous multiple primary colorectal cancer; 2. preoperative imaging examination results show: (1) colon cancer of stage t1n0; (2) enlargement of lymph node at the root of mesocolon, in which case the d3 radical operation must be performed; 3. preoperative imaging examination results show: (1) tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform r0 resection; 4. history of any other malignant tumor in recent 5 years, except for cervical carcinoma in situ which has been cured, basal cell carcinoma or squamous cell carcinoma of skin; 5. patients need emergency operation; 6. not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc). 7. informed consent refusal

Keywords: right colon cancer, survival, laparoscopic surgery
impact online clinical study

Conditions: Brain Concussion

Summary: the researchers want to find out more about a standalone software application, impact online and how it relates to other commonly used tests of memory, attention and reaction time. impact online is a computer-based neurocognitive test for concussion management. the test was designed to help measure the effects of concussion on cognitive processes (for example, memory, attention, brain speed) and visual functioning.


Eligibility criteria:
inclusion criteria: * age: 12-59 * primary english speaking or fluent in english. * no known special education diagnosis excluding a 504 designation. * currently not suffering from a concussion or being treated for a concussion. * no known physical or psychological impairment that would affect their ability to perform the test. * an average or above average score on the rist (reynolds intellectual screening test). exclusion criteria: * documentation of a known special education diagnosis other than a 504 designation. * english is not their primary language nor are they proficient in the english language. * currently suffering from a concussion or being treated for a concussion. * a below average score on the rist.
platelet rich plasma in plantar fasciitis

Conditions: Plantar Fascitis

Summary: a number of patient diagnosed as degenerative plantar fasciitis will be collected and divided into two groups, group i will be injected by platelet rich plasma and group ii will be injected methylprednisolone

the study will include 100 patients diagnosed as degenerative plantar fasciitis and will be evaluated by musculoskeletal ultrasound by two observes and the will divided randomly into two groups who will be injected under ultrasound imaging by either platelet rich plasma or methylprednisolone. selection of patient will be randomly and the study will be double blinded.

Eligibility criteria:
inclusion criteria: \* clinical diagnosis of plantar fasciitis exclusion criteria (history or current): * rheumatic diseases * foot trauma * neurological diseases * thyroid disease * diabetes mellitus * chronic renal failure

Keywords: degenerative plantar fasciitis platelet rich plasma ultrasound guided injection heel pain interventional rheumatology
eus-guided fna in the study of the adrenal gland

Conditions: Adrenal Gland Disease; Adrenal Tumor

Summary: to analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the eus-fna with ag. national multicenter retrospective study. mailing-seed partners. participation: 17 spanish centers. inclusion period: april / 2003 to april / 2016 inclusion criteria: all ag (left / right) punctured by eus. a review of 205 eus-fna of ag in 200 patients is included.

introduction: the eus has proven useful in the study and evaluation of the adrenal gland (ag) by endoscopic ultrasound-guided fine-needle aspiration (eus-fna), in both the left and right glands. objective: to analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the eus-fna with ag. materials and methods: national multicenter retrospective study. mailing-seed partners. participation: 17 spanish centers. inclusion period: april / 2003 to april / 2016 inclusion criteria: all ag (left / right) punctured by eus. variables reviewed: demographic characteristics, clinical, extension studies, use and pathological data. comparison between variables; and estimation of multivariate logistic model for cytology, mortality and therapeutic change.

Eligibility criteria:
inclusion criteria: * all adrenal gland (left / right) punctured by endoscopic ultrasound

Keywords: adrenal gland endoscopic ultrasound guided fna